Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation (BFe01B1)

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ClinicalTrials.gov Identifier: NCT00760890

Recruitment Status :
Completed

First Posted : September 26, 2008

Last Update Posted : September 26, 2008

Sponsor:

National Institutes of Health (NIH)

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Official Title ICMJE

Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Brief Summary

Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.